Cardiac Biomarkers in Patients With Single Ventricle Physiology

NCT03678909 | Completed

• 1 other identifier: H-42776
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule. These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

Conditions

Hypoplastic Left Heart; Congenital Heart Disease; Cyanotic Congenital Heart Disease; Cardiac Disease

Keywords

Troponin; BNP; Biomarkers; Hypoplastic Left Heart; Norwood; DKS

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality up to anticipated Glenn Procedure

  3- 6 months depending on second stage procedure

Secondary Outcomes (3)

• NEC

  3- 6 months depending on second stage procedure

• Reintubation

  3- 6 months depending on second stage procedure

• Cath intervention

  3- 6 months depending on second stage procedure

Study Arms (1)

Hypoplastic Left Heart Disease

Patients with congenital hypoplastic left heart disease who will undergo surgical palliation with Norwood procedure or DKS or Damus-Kaye-Stansel procedure

Procedure: Norwood Palliation / DKS / Damus-Kaye-Stansel procedure

Interventions

Norwood Palliation / DKS / Damus-Kaye-Stansel procedure PROCEDURE

Norwood Palliation / DKS / Damus-Kaye-Stansel procedure

Hypoplastic Left Heart Disease

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonate with Hypoplastic Left Heart Syndrome

You may qualify if:

• Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate

You may not qualify if:

• Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome; Heart Defects, Congenital; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marc M Anders, ND

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: September 20, 2018
• Study Start: March 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)